COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226

K063543 · Roche Diagnostics Corp. · CIG · Dec 22, 2006 · Clinical Chemistry

Device Facts

• Record ID: K063543
• Device Name: COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
• Applicant: Roche Diagnostics Corp.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Dec 22, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1110
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

COBAS INTEGRA Bilirubin Direct: The cassette COBAS INTEGRA Bilirubin Direct (BIL-D) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the direct (conjugated) bilirubin concentration in serum and plasma (test BIL-D, 0-049). COBAS INTEGRA Total Bilirubin Special: The COBAS INTEGRA Total Bilirubin Special (BILTS) cassette contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of total bilirubin in serum and plasma of adults and neonates (test BILTS, 0-985). Roche Hitachi Total Bilirubin Special: For the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi automated clinical chemistry analyzers. Measurement of the levels of bilirubin and organic compound formed during the normal and abnormal distruction of red cells, if used in the diagnosis of liver, hemolytic hemoatological, and metabolic disorders, including hepatitis and gall bladder block

Device Story

In vitro diagnostic reagent systems for quantitative bilirubin measurement in serum/plasma; used on COBAS INTEGRA and Roche/Hitachi automated clinical chemistry analyzers. Principle of operation: Diazo method. Modifications include updated traceability to Doumas reference method, revised reagent pH, updated lower detection limits, and refined interference specifications (lipemia/hemolysis). Operated by laboratory technicians in clinical settings. Output is quantitative bilirubin concentration; used by clinicians to diagnose liver, hemolytic, hematological, and metabolic disorders. Benefits include standardized, accurate bilirubin monitoring for adults and neonates.

Clinical Evidence

Bench testing only. Performance verified through interference testing, sensitivity analysis (lower detection limit), and validation of reagent modifications against predetermined acceptance criteria.

Technological Characteristics

In vitro diagnostic reagents; Diazo method. Reagent composition includes sodium acetate buffer, sulfamic acid, hydrochloric acid, and diazonium ion. Automated analysis on COBAS INTEGRA and Roche/Hitachi systems. Traceability to Doumas reference method. Software-controlled automated clinical chemistry analyzer platform.

Indications for Use

Indicated for the quantitative determination of bilirubin in human serum and plasma.

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Predicate Devices

• COBAS INTEGRA Bilirubin Direct (k951595)
• COBAS INTEGRA Total Bilirubin Special (k981632)
• Roche/Hitachi Bilirubin Total (k981632)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k063543

This 510(k) submission contains information/data on modifications made to the SUBMITTERS own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTERS previously cleared device. (For a preamendments device, a statement to this effect has been provided.) COBAS INTEGRA Bilirubin Direct k951595; COBAS INTEGRA Total Bilirubin Special k981632; Roche/Hitachi Bilirubin Total k981632.
2. Submitters statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, users and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for additional interference testing, reagent alteration, lower detection limit, specimen collection and recommended calibrator.

4. Comparison Information (similarities and differences) to applicants legally marketed predicate device including labeling, intended use, physical characteristics, test principle, measuring range, interference, and recommended calibrator.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitters description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.